A Multicenter Clinical Study on the Continuous vs. Intermittent Infusion of Ceftazidime-Avibactam in Critically Ill Patients With Severe Infections

NCT ID: NCT06939829

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-12-31

Brief Summary

The objective of this study is to determine whether continuous infusion of ceftazidime-avibactam (CAZ-AVI) could improve clinical outcomes in critically ill patients compared with intermittent infusion.

Detailed Description

This study employs a prospective, open-label, randomized controlled, multicenter clinical trial design comparing "CAZ-AVI continuous infusion" versus "CAZ-AVI intermittent infusion," .The secondary objectives is to observe the clinical cure, Bacterial clearance, the probability of target attainment (PTA) of TDM. etc

Conditions

Patients With Critically Ill Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

the intermittent infusion group

Ceftazidime-avibactam will be administered as 2.5 g q8h by intermittent infusion for 2 h, and the dosage could be adjusted according to the instructions.

Group Type: ACTIVE_COMPARATOR

treatment with CAZ-AVI

Intervention Type: DRUG

Randomize subjects to receive CAZ-AVI via either continuous infusion or intermittent infusion. The total daily dose and dosing interval should be determined according to the subject's body weight, renal function, and estimated drug clearance based on standard prescribing guidelines. Regardless of administration method, the same criteria for dose adjustment (including indications for modification and monitoring parameters) must be consistently applied to both control and experimental groups.

the continuous infusion group

After a loading dose of ceftazidime-avibactam, continuous infusion is administered, with the dose adjustment rules consistent with those of the intermittent infusion group.

Group Type: EXPERIMENTAL

treatment with CAZ-AVI

Intervention Type: DRUG

Randomize subjects to receive CAZ-AVI via either continuous infusion or intermittent infusion. The total daily dose and dosing interval should be determined according to the subject's body weight, renal function, and estimated drug clearance based on standard prescribing guidelines. Regardless of administration method, the same criteria for dose adjustment (including indications for modification and monitoring parameters) must be consistently applied to both control and experimental groups.

Interventions

treatment with CAZ-AVI

Randomize subjects to receive CAZ-AVI via either continuous infusion or intermittent infusion. The total daily dose and dosing interval should be determined according to the subject's body weight, renal function, and estimated drug clearance based on standard prescribing guidelines. Regardless of administration method, the same criteria for dose adjustment (including indications for modification and monitoring parameters) must be consistently applied to both control and experimental groups.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18-85 years old, male or female.
• Patients who are admitted to ICU wards.
• Patients clinically diagnosed with carbapenem-resistant organism (CRO) infections, and has been commenced on targeted therapy with ceftazidime-avibactam.
• One or more organ dysfunction criteria in the previous 24 hours i. MAP < 60 mmHg for at least 1 hour; ii. Vasopressors required for > 4 hours; iii. Respiratory support using supplemental high flow nasal prongs, continuous positive airway pressure, bilevel positive airway pressure or invasive mechanical ventilation for at least 1 hour.

iv. Serum creatinine concentration > 220 μmol/L or >2.49 mg/dL

Exclusion Criteria

• Patient has a known allergy to ceftazidime-avibactam.
• Patient has received ceftazidime-avibactam for more than 48 hours during current infectious episode.
• Patient is in severe condition or expected to survive for no more than 48 hours.
• Patient who receives lung or heart transplant or stem cell transplant.
• Patient is known or suspected to be pregnant.
• Patient has previously been enrolled in the current study.
• Other conditions which are regarded as inappropriate for enrollment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southeast University, China

OTHER

Sponsor Role: lead

Responsible Party

Jianfeng Xie

director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feng jian Xie, MD

Role: STUDY_CHAIR

Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University

Central Contacts

feng jian Xie, MD

Role: CONTACT

xie820405@126.com

+86-025-83262552

Lin lin Hu, PhD

Role: CONTACT

eliza50@sina.com

+86-025-83272127

Other Identifiers

2025ZDSYLL022

Identifier Type: -

Identifier Source: org_study_id